Biospecimen Project Manager

The Biospecimen Project Manager will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies.

Responsibilities:

Drive biospecimen lifecycle management from sample receipt to analysis and final disposition Ensure accurate specimen metadata Transfer analytical data to clinical repository Increase the efficiency of specimen management through sharing of knowledge and best practices Participate in or lead special projects as assigned Adhere to client policies and Standard Operating Procedures Review nonclinical and clinical study protocols and service providers scope of work documents for sample handling and processing details Set up study and electronic protocol in LIMS Create and manage project plans Manage data transfer plans with analytical laboratories Manage specimen metadata discrepancies and ensure resolution Submit specimens for analytical assays per study timelines Provide specimen updates of received specimens and data to study teams Review status of specimens received and completeness of data in data system; create reports for study teams when requested Contribute to meeting database locks by ensuring all specimens have a final result and data transfer is complete; create reports for data management as needed Participate in and/or lead process improvement projects under direction of manager Support manager in providing projections for annual and long-term planning

Education/Experience:

Understanding of transaction-based inventory and data management systems as well as clinical trial processes Understanding of ICH, GCP, GLP, and local regulations Proficient in Excel, macro and template building knowledge Strong planning, organizational, time management skills Experience with StarLIMS or other LIMS for biospecimen management

B.A./B.S.

in life sciences, medical technology, or related field and min 3-5 years of directly related experience. Experience in life sciences or medically related fields, including clinical development, biospecimen lifecycle management, or clinical laboratory analysis. Project Management experience is also preferred. Very high attention to detail and excellent multi-tasking skills are required for success in this position.